Testosterone undecanoate
Testosterone undecanoate or testosterone undecylate is an ester of testosterone. This hormone is used in androgen replacement therapy
primarily for the treatment of male hypogonadism, and is currently under research for
use as a male
contraceptive. It is sold and distributed under the brand names Andriol,
Undestor, Nebido, Pantestone, Restandol, Cernos Depot and Nebido-R and Reandron
1000 ref 1
- Köhn, FM; Schill, WB (Nov 2003). "A new oral testosterone undecanoate formulation.". World J Urol 21 (5): 311–5. doi:10.1007/s00345-003-0372-x. PMID 14579074.
- testosterone undecanoate at the US National Library of Medicine Medical Subject Headings (MeSH)
http://www.bioportfolio.com/news/article/1484561/Endo-Pharma-gets-CTL-from-FDA-relating-to-testosterone-drug-Aveed.html
USA-based Endo Health Solutions (Nasdaq: ENDP) says that the US Food and Drug Administration has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for subsidiary Endo Pharmaceuticals' long-acting testosterone undecanoate injection, Aveed, for men diagnosed with hypogonadism.
The complete response letter did not include requests for the company to perform additional clinical studies. The FDA outlined the steps necessary to support approval of the NDA and updated the requirement for a Risk Evaluation and Mitigation Strategy (REMS). Specifically, the FDA has requested that the REMS include a Medication Guide as well as Elements to Assure Safe Use (ETASU) to mitigate the risks and severe complications related to post-injection reactions
read all at
http://www.thepharmaletter.com/file/122512/endo-pharma-gets-ctl-from-fda-relating-to-testosterone-drug-aveed.html
No comments:
Post a Comment